Trial Outcomes & Findings for Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00176631)
NCT ID: NCT00176631
Last Updated: 2023-12-22
Results Overview
Decline from baseline value by \> 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
9 months
Results posted on
2023-12-22
Participant Flow
Ten subjects were enrolled from April 2004 through November 2006 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center, and one of its affiliate hospitals within the CINJ Oncology Group.
Participant milestones
| Measure |
Licorice Root Extract and Docetaxel
licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Licorice Root Extract and Docetaxel in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Licorice Root Extract and Docetaxel
n=10 Participants
licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: No data collected
Decline from baseline value by \> 50%, or normalization of PSA (defined as PSA less than 0.2 ng/ml), confirmed by a second measurement at least 1 or more weeks later.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 monthsPopulation: No data collected
Outcome measures
Outcome data not reported
Adverse Events
Licorice Root Extract and Docetaxel
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Licorice Root Extract and Docetaxel
n=10 participants at risk
licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
|
|---|---|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • Number of events 1 • 9 months
|
Other adverse events
| Measure |
Licorice Root Extract and Docetaxel
n=10 participants at risk
licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.
docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.
|
|---|---|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
80.0%
8/10 • Number of events 11 • 9 months
|
|
General disorders
Constitutional Symptoms - Other
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
General disorders
Sweating (diaphoresis)
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
60.0%
6/10 • Number of events 22 • 9 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
60.0%
6/10 • Number of events 24 • 9 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
30.0%
3/10 • Number of events 6 • 9 months
|
|
Gastrointestinal disorders
Diarrhea patients without colostomy
|
30.0%
3/10 • Number of events 5 • 9 months
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
2/10 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Dehydration
|
20.0%
2/10 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 3 • 9 months
|
|
Gastrointestinal disorders
Dysphagia, esophagitis, odynophagia (painful swallowing)
|
10.0%
1/10 • Number of events 2 • 9 months
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Nervous system disorders
Neuropathy-sensory
|
20.0%
2/10 • Number of events 2 • 9 months
|
|
Psychiatric disorders
Confusion
|
10.0%
1/10 • Number of events 2 • 9 months
|
|
Nervous system disorders
Dizziness/lightheadedness
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Nervous system disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
General disorders
Pain
|
40.0%
4/10 • Number of events 4 • 9 months
|
|
General disorders
Bone pain
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
20.0%
2/10 • Number of events 2 • 9 months
|
|
Cardiac disorders
Edema
|
30.0%
3/10 • Number of events 3 • 9 months
|
|
Cardiac disorders
Hypotension
|
10.0%
1/10 • Number of events 2 • 9 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Ear and labyrinth disorders
Auditory/Hearing - Other
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Infections and infestations
Infection without neutropenia
|
10.0%
1/10 • Number of events 2 • 9 months
|
|
Investigations
Hypermagnesemia
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
10.0%
1/10 • Number of events 1 • 9 months
|
|
Renal and urinary disorders
Incontinence
|
10.0%
1/10 • Number of events 1 • 9 months
|
Additional Information
Dr. Robert DiPaola, MD
Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place